Communities need to be involved in research -- not just as participants, but also in shaping the research project, say AVAC and UNAIDS' Good Participatory Practices guidelines (GPP). But how are these guidelines implemented, and what is the outcome? Researchers shared their experience with and research into community participation at the 10th International AIDS Society Conference on HIV Science in Mexico City in July.
Holly L. Peay, Ph.D. , of RTI International explained her social science team's involvement in several clinical trials among people with acute HIV in Thailand. At the study site, potential participants were interviewed about their decision to enroll or not enroll in the study. The team also surveyed the clinical researchers involved and shared their results with them. All 18 clinicians responded to the initial survey in 2017, and 15 responded to the second survey in June 2019. Most viewed embedding this social science research into their clinical trials positively but were unsure about the implications of the social science findings for their future work.
"Anecdotally, several of them said to us, 'This is really great, but how do we fix it?'" said Peay. "That is what our team is moving towards now -- developing interventions and tools so that clinicians on the ground have ways to address the ethical issues that we uncovered."
Karen Buleza of Janssen Pharmaceuticals reported on implementing GPP in her company's HIV vaccine research. She noted that too often, research is still conducted on communities. "This is something that must change," she said, explaining that her company is committed to conduct its trials with communities and participants. Based on the UNAIDS GPP, Janssen developed its own guidelines, as well as templates and examples to aid implementation.
For Buleza, including GPP means determining, "What are the questions I need to be asking from a GPP perspective [to make sure] that I am keeping participants and their communities at the heart of every aspect, in our protocol development, in our trial conduct?" The GPP process has, for example, led to lay language summaries of the APPROACH phase 2 study's interim analysis, which were then shared with trial participants. "The plan is to implement this in all of the work we do, not just in HIV and future pediatric trials, but in all therapeutic areas," she concluded.
Kathleen M. MacQueen, Ph.D., of the University of North Carolina told attendees about a conceptual map of stakeholder beliefs that her team developed. While 121 people enrolled in this study, only 82 answered at least one of five surveys, and each individual questionnaire had between 31 and 55 respondents. About Survey 1, MacQueen said, "We had 54 of our panelists responding, and they had a very clear consensus across all of the stakeholder groups that the goal of GPP is to make sure clinical trials are ethical and scientifically sound." An open-ended follow-up survey generated almost 300 strategies for achieving this goal. The next step is practical use of this data.
"Importantly, we want to begin translating this into a practical evaluation guide for the way that we do GPP," said McQueen.
"I am going to talk to you today about the importance of early, ongoing, and iterative community engagement in clinical trial research," Michele Andrasik, Ph.D., of the University of Washington announced. She explained how the two AMP studies testing the efficacy of broadly neutralizing antibodies for HIV prevention used community input to mitigate the expected difficulty in enrolling and retaining participants.
"Most importantly, it is about building relationships, and maintaining those relationships that we have already established," she said. Community engagement was focused on educating both community members and health care providers about the trial. The team sought community input in various stages of creating four recruitment videos, from script development to final review. "We also realized through much of our previous work that it is incredibly critical to develop geographically specific materials," Andrasik explained.
To that end, professionally translated text was adapted locally by community working groups, and local photo shoots provided more representative images than could be achieved with stock photos. Input from research sites was also sought for retention strategies, and clinical research staff were trained in cultural responsiveness. "We have conducted follow-up formative research and have found that one of the major retention factors is the way that our CRS [clinical research site] staff treat our participants," she said.
Miriam A. Hartmann, M.P.H., of RTI International showed examples of how South African youth were involved in the iPrevent study, which is investigating young people's uptake and adherence to potential long-acting HIV prevention options. Researchers created a youth community advisory board and recruited additional young people for input on specific aspects of the project. Youth served as co-designers of the product and recruitment materials, as well as filmmakers, reviewing the language and images used. Community board members emphasized the need to focus materials on basic pre-exposure prophylaxis (PrEP) education and highlight men's responsibility for HIV prevention.
"Taking an iterative approach really facilitated our ability to respond to their needs and what they wanted in terms of engagement in the research process," Hartmann explained.
One example of community responses significantly changing a study was provided by an audience member. Her team went into schools to test a community intervention on HIV prevention. Talking to the schools' principals, however, they learned that suicide and depression were the most pressing issues there at the time. Researchers revised the intervention to deal with mental health issues before approaching the question of HIV prevention.
Panel members agreed that community involvement in the conduct of clinical trials is important, but differed on exactly when and how that input is solicited. GPP processes are not yet standardized, but some of the studies presented are developing such tools. Open questions remain, including who owns the data generated and how to best ensure that people who represent the community, rather than "superstars," are included on advisory panels and similar bodies.